The Senior Manager of Supply Chain Planning is responsible for strategic and tactical planning operations and leading supply chain system implementation efforts at BlueRock Therapeutics. Reporting into the Director of Supply Chain, this role supports all BlueRock research, development, and clinical GMP manufacturing teams by formulating planning scenarios, business lead for supply chain system implementation, enhancing reporting and analytical capabilities, and remediating supply and quality risks of critical raw materials with suppliers. In addition, this role develops and continuously drives best practices such as decision making, integrated planning operations, and internal communication with responsibilities framework.
Responsibilities:
- Business lead for supply chain system implementation and operations. Support IT and cross functional teams to generate user requirements, manage project workstreams to facilitate on-time delivery, and lead life cycle management strategies within Technical Operations.
- Develop and manage a BlueRock-wide integrated planning processes that aligns demand, supply, and resources accordingly to meet CMC development, and clinical goals.
- Lead cross functional teams to remediate supply and quality risks of critical raw materials with suppliers for ongoing and upcoming CMC programs/platforms in the BlueRock pipeline.
- Lead and represent Supply Chain in the CMC governance cross functional programs from concept to phase 3 stage gate deliverables.
- Develop and implement supply chain reporting and analytics including planning/scheduling metrics, safety stock policies, inventory and risk management, and internal data collection.
- Manage and streamline procurement/purchasing activities for all BlueRock sites ensuring continuity of supply for all research, development, and clinical manufacturing.
- Participate and support in vendor qualifications, quality agreements and audits/inspections.
- Manage any operational documentation or data returned from clinical sites to incorporate into BlueRock GMP Quality System.
- Ensure all tasks are completed in a safe and compliant manner considering relevant BlueRock procedures/policies, regulatory guidance, and current practices (GMPs) for all aspects of Supply Chain and Logistics.
Minimum Requirements:
- Minimum of a Bachelors degree in scientific discipline or related field is required.
- Minimum of 13 years of related or equivalent work experience in supply chain or technical operations role is required.
- Minimum of 3 years of relevant planning and/or project leadership experience is required.
- Direct experience with implementing business processes, Oracle/SAP, production planning, inventory control and warehousing & distribution is required.
- General understanding of pharmaceutical supply chain including serialization is preferred.
- Experience working in GxP pharmaceutical and/or biotechnology regulated environment is required.
- Experience in representing the function as Subject Matter Expert (SME) and defending GxP systems in audit setting is required.
- Highly functional in a fast-paced, dynamic company with ability to adapt to changing timelines and priorities required.
- Excellent written and verbal communication skills are a must.
- Experience with relevant legal standards and compliance systems is required.
- Working knowledge of Quality Assurance (QA) and Environmental, Health & Safety (EHS) standards is required.
- Demonstrated application of quality and efficiency improvement methods such as LEAN, Six Sigma is preferred.
- Experience in working with electronic systems such as ERP, LIMS, CMMS, WMS is required.
- Ability to analyze and resolve problems independently.
- You may, on occasion, be asked to lift 20kg and/or work with a partner to lift anything heavier.
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What We Do
BlueRock Therapeutics is a leading engineered cell therapy company with a mission to develop regenerative medicines for intractable diseases. BlueRock Therapeutics’ cell+gene platform harnesses the power of cells to create new medicines for neurology, cardiology, and immunology indications.
BlueRock Therapeutics’ cell differentiation technology recapitulates the cell’s developmental biology to produce authentic cell therapies, which are further engineered for additional function. Utilizing these cell therapies to replace damaged or degenerated tissue brings the potential to restore or regenerate lost function.
BlueRock’s culture is defined by scientific innovation, the highest ethical standards and an urgency to bring transformative treatments to all who would benefit. The company strives to be a top employer of scientific talent, empowering every member of the team to make meaningful and lasting contributions to the burgeoning field of regenerative medicine.
Become a BlueRocker! We are expanding our BlueRock team at all locations. Contact us via LinkedIn or our website to learn about rewarding career opportunities.